Bioprocessing involves usage of complete living cells such as bacteria, enzymes and chloroplast to obtain desired products. Bioprocessing includes multiple stages such as fermentation, buffer media, filtration, formulation and filing and so on. Bioprocessing includes upstream bioprocessing and downstream bioprocessing. The upstream process is a process that involves early cell isolation and cultivation, to cell banking and culture expansion of the cells until final harvest (termination of the culture and collection of the live cell batch. The upstream bioprocess involves growing microbes/cells, e.g. bacterial or mammalian cell lines in bioreactors. This process involves all the steps related with inoculum development, media development, improvement of inoculum by genetic engineering process, optimization of growth kinetics so that product development can improve tremendously. Fermentation process includes two parts i.e. upstream and downstream processes. After product development, the next step is purification of product for desired quality. When they reach the desired density they are harvested and moved to the downstream section of the bioprocess. The downstream bioprocess refers to a process where the cell mass from the upstream are processed to meet purity and quality requirements. Downstream processing is usually divided into three main sections i.e. cell disruption, purification section and polishing section. The volatile products can be separated by distillation of the harvested culture without pre-treatment. Distillation is done at reduced pressure at continuous stills. At reduced pressure distillation of product directly from fermenter may be possible.
Traditional bioprocess uses dedicated series of bioreactors linked together with valves and rigid piping for production. A cleaning system is installed within each bioreactor, vessel and piping line to remove residual materials. Further sterility assurance at the start of each culture is achieved by a steam in place system including steam pipes, temperature sensors, and condensate collecting pipe. Both the cleaning system and the steam in place system require extensive validation testing. Also the valves and pipes require more validations. These valves and pipes need significant maintenance and changes that amounts to revalidation.
Multiple bio-reactors may be connected using tubes and pipes. These tubes and pipes are mostly single use and need to be sterile. The tubes used may be thermoplastic tubes. The connections between bio-reactors, containers, tube sets, and bioprocess equipments are completed using aseptic connectors. The connectors also need to be sterilized if reused or need to be disposed-off after one use. Multiple tubes may be connected to each other using aseptic connection i.e. a tube welder or fuser in a sterile manner. The fuser or a fusing device is typically a large size device that can connect different tubes of varying diameters. The device can perform fully automated operations and they can do thermal welding with exception strength. The fuser device is typically heavy which restricts its mobility.
Sealers are used to seal connections of bags and other containers for storage and transportation. These sealing needs to be leak proof and tamper proof to ensure that media, buffer or products do not leak through the tubing clamps, plugs or hemostats during transportation and storage. Sealers are also typically table top devices and are bulky. Also separate devices for sealing and fusing needs to be carried by the user for performing in these operations for fusing tubes and sealing a tube used in bioprocessing environment. These can make the activities of sealing and fusing more labor some. Moreover, in general there is a need for having two separate devices i.e. a fuser and a sealer to perform fusing and sealing operations for aseptic connections which results in big capital investments, requires more space and also flexibility is lost.
Therefore, there is a need for an improved system for sealing and fusing tubes or pipe used in bioprocess equipments.